LCS COMPLETE 1294-29-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295025535), received between Apr 24, 2019 and Oct 30, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS COMPLETE REVISION COMPONENTS. IMPLANTS REVISED DUE TO SUSPECTED INFECTION AND LOOSENING. VERY MINIMAL BONE GROWTH ON THE STEM AND SLEEVE. IMPLANTS WERE REMOVED VERY EASILY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20567759 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH A PAINFUL KNEE AND SCANS SHOWED THE IMPLANT WAS LOOSE BOTH THE FEMUR AND THE TIBIA AND THE PATIENT WAS EXPERIENCING INSTABILITY. NO INFECTION WAS FOUND. DOI: (B)(6) 2019. DOR: (B)(6) 2022. LEFT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14985773 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN LCS REVISION DUE TO LOOSENING, INFECTION AND FRACTURE (LOOSENING AND FRACTURE ARE UNSPECIFIED). DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10727004 ↗
• InjurySep 18, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE. DEPUY CEMENT WAS USED. SURGEON REMOVED THE LCS FEMUR AND FEMUR SLEEVE, REPLACED WITH A TC3 FEMUR WITH AUGMENTS, FEMUR SLEEVE, STEM AND NEW POLY. DOI: (B)(6) 2015. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9083248 ↗
• MalfunctionApr 24, 2019Difficult to Insert; Difficult to Insert

  IT WAS IMPOSSIBLE TO ATTACH THE 5MM STD+ AUGMENT TO THE FEMORAL COMPONENT. THEY TRIED TO ATTACH A STD 5MM AUGMENT ALSO, BUT IT WAS IMPOSSIBLE TO GET IT ATTACHED TO THE FEMUR. THEY IMPLANTED THE FEMUR WITHOUT AUGMENT AND WITH EXTRA CEMENT. OPENED ANOTHER IMPLANT, BUT WAS ALSO IMPOSSIBLE TO ATTACH. 20 MINUTE DELAY.

  Patient problems: Not Applicable

  MAUDE report 8544153 ↗